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NCT00296036 · ClinicalTrials.gov registry record · Phase 3

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
137
Enrollment target

NCT00296036 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 137 participants.

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The verdict

NCT00296036, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
137 participants
Enrollment target

Study Summary

RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome. PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.

Interventions

  • OTHER placebo
  • DIETARY_SUPPLEMENT pyridoxine hydrochloride
  • DRUG urea/lactic acid-based topical cream

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2006-06
Phase Phase 3

What the Registry Record Tells You About NCT00296036

The ClinicalTrials.gov registry entry for NCT00296036 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 137 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 446 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.

NCT00296036 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00296036 about?

NCT00296036 is a clinical study titled "Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer". RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream ...

What is the current status of trial NCT00296036?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2006-06.

What interventions are being tested in trial NCT00296036?

The interventions under investigation include: placebo (OTHER), pyridoxine hydrochloride (DIETARY_SUPPLEMENT), urea/lactic acid-based topical cream (DRUG).

Who is sponsoring clinical trial NCT00296036?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.